AccessGUDID - DEVICE: INTEGRA 3 (05060488041815)

GUDID

Device Identifier (DI) Information

Brand Name: INTEGRA 3
Version or Model: Integra 3 Thermosafe Olympus 1 x SAS & 1 x SAS-SE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6-54-100-07
Company Name: RESEARCH INSTRUMENTS LIMITED

Primary DI Number: 05060488041815
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 536139413 *Terms of Use

Device Description: Assisted Reproduction Micromanipulator and Microinjector

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34169	Assisted reproduction electromechanical micromanipulator	An electrically-powered device designed for accurate manipulation of microscopic objects during laboratory in vitro assisted reproduction techniques (ART) [e.g., intracytoplasmic sperm injection] usually by making small movements under the visual field of a laboratory microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, syringe microinjectors, capillary tubes). The device does not perform its actions following a computerized program.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQJ	MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003142	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6134536c-96d1-496d-8578-ce68b8c6cbb0
Public Version Date: February 28, 2024
Public Version Number: 5
DI Record Publish Date: December 22, 2017